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Monday, 17 June 2013

Catering for all tastes, this weblog has provided (i) the breaking news announcement by Jeremy that the US Supreme Court had given its ruling in Myriad Genetics and (ii) a mouth-watering hors d'oeuvres from guest Kat Matthias together with Roberto Romandini in the form of some succinct comments on that decision. Now's the time for (iii) the main course -- elegantly prepared and eloquently presented by IP master chef and former guest Kat Norman Siebrasse. This is Norman's take on the decision, flavoured with some delicious thoughts of his own:

In Myriad
Genetics the USSC has held, in a unanimous decision, that claims to
isolated DNA are not patentable subject matter, but that claims to cDNA are
patentable. The Myriad Genetics
decision is better than I had anticipated after the disappointingPrometheus decision -- and not only because of the holding
regarding cDNA. The Court’s reasoning turned primarily on its misguided rule
against patenting “laws of nature,” and to that extent it is seriously flawed,
but there are hints of a better analysis. Moreover, the Court expressly noted
that “this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . .
. Many of its unchallenged claims are
limited to such applications” (original emphasis). There is also an important
negative point: the Court did not reaffirm its traditional “preemption” rationale
for its rule against patenting laws of nature. This suggests that by claiming
applications of knowledge relating to newly discovered genes, an inventor may
be able to gain the same practical protection as would be possible by a claim
to the gene itself.

The patent systems I am familiar with,
including the US, the EPC, and the UK pre-EPC, all have a rule against
patenting abstract ideas. (For the origin of the rule, see here.) In UK and Canadian law, this is
understood as an objection to patenting abstract
ideas: “A disembodied idea is not per se patentable. But it will be patentable
if it has a method of practical application.” (Shell Oil[1982] 2 SCR 536 at 554, summarizing UK case law.)
Laws of nature are often assimilated to abstract ideas, and often, as with “F =
ma” stated as such, this is sound. But starting with Funk Brothers , 333 US 127 (1948), the USSC has interpreted this as
a rule against patenting inventions based on laws of nature. This is very
different. As Frankfurter J pointed out in Funk
Bros “[e]verything that happens may be deemed ‘the work of nature,’ and any
patentable composite exemplifies in its properties ‘the laws of nature.’
Arguments drawn from such terms for ascertaining patentability could fairly be
employed to challenge almost every patent.” Unfortunately, Frankfurter J was in
the dissent on this point, and the result has been that the USSC has tended to
strike down claims where it is intuitively clear that the invention rests on a
discovery of nature, while upholding claims where the invention is, on the
surface, a thing. (For a detailed review and critique of the US law on this
point, see here.)

This same fallacious reasoning continues in Myriad Genetics when the Court noted
(slip op 11-11) that

It is undisputed that Myriad did not
create or alter any of the genetic information encoded in the BRCA1 and BRCA2
genes. The location and order of the nucleotides existed in nature before
Myriad found them. Nor did Myriad create or alter the genetic structure of DNA.
Instead, Myriad’s principal contribution was uncovering the precise location
and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.
The question is whether this renders the genes patentable.

Conversely, “the lab technician unquestionably
creates something new when cDNA is made” (slip op 17), and it is therefore
patentable. This seems to conceive of the invention as a thing, namely the gene
itself, which Myriad admittedly did not create, or the cDNA, which it is did
create. But in either case, Myriad’s real contribution was knowledge about the
function of the gene. And, as Sir Hugh Laddie, has explained, “The invention
is a novel mental concept which is embodied in, or exploited through, new
products or processes. The patent's function is to enable that concept to be
protected in exchange for publishing it to the world so that, after expiry, the
public can use it” (American Home
Products v Novartis [2000] RPC 547 (Pat) [18], my emphasis). More pithily,
Lord Hoffmann noted in Merrell Dow
[1996] RPR 76 noted that “An invention is a piece of information.”

With that said, that an invention is
information does not imply that the information may be claimed as such. The
rule against abstract claims places limits on how information may be claimed.
The Myriad Genetics decision hints at
this in its response to the argument that isolated DNA is just as unnatural as
cDNA:

Myriad’s claims are simply not
expressed in terms of chemical composition, nor do they rely in any way on the
chemical changes that result from the isolation of a particular section of DNA.
Instead, the claims understandably focus on the genetic information encoded in
the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a
unique molecule, then a would-be infringer could arguably avoid at least
Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282
patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene
and one additional nucleotide pair. Such a molecule would not be chemically
identical to the molecule “invented” by Myriad. But Myriad obviously would
resist that outcome because its claim is concerned primarily with the
information contained in the genetic sequence, not with the specific chemical
composition of a particular molecule.

This suggests that the Court’s real objection
is not that the patents claimed naturally occurring DNA, but rather that it
claimed “presentations of information . . . as such,” to put in the terms of EPC Art 52. The difficulty with the Court’s
reasoning here is that a proper analysis of this issue would turn on how the
claims are construed. It is no doubt true that the claim is “concerned
primarily” with the information, but that alone does not make it a claim to
information as such, rather than a claim to a molecule embodying that
information. The Court seems to have assumed that because the claim is about
information, is therefore a claim to information. This again reflects
the basic misunderstanding that has dogged the USSC analysis of patentable
subject matter for decades: the USSC cannot seem to grasp that there is a
difference between a claim to an idea, and a claim to an application embodying
that idea. So, this passage is at most a hint at a better analysis, rather than
a sound justification for the decision.

How would a proper analysis proceed? Though
that rule against abstract claims is fundamental, it has seldom been applied to
strike down a claim, and its precise bounds are not clear.I have argued that the rule against abstract
claims is probably best justified by the difficulty of determining the bounds
of such claims. For example, Morse’s famous eighth claim at issue in O'Reilly v Morse 56 US 62 (1854), to the
use of electromagnetism for communication at a distance, should have been held
invalid as being anticipated, not just for overbreadth: the claim would
encompass semaphores, as light is a form of electromagnetism. But no one could
appreciate this at the time, as it was not known that light and
electromagnetism were linked. Put another way, if an invention is claimed as a
theory, it is necessary for a defendant to know the theory of how its gizmo
works in order to know whether it infringes the claim. When an invention is
claimed as an application, all that is necessary is to see whether the
practical application is the same. On this rationale, a claim to isolated DNA
might be invalid if the claim did not provide adequate notice to other as to
what activity would be infringing. I suspect that on a proper construction of
the claim, a claim to isolated DNA would not offend the rule against abstract
claims; but that conclusion would require a very different analysis from that
provided in Myriad Genetics.

While the reasoning in Myriad Genetics is deficient, the Court did indirectly affirm one
half of the traditional rule as stated in Shell
Oil, namely that applications of knowledge are patentable, when it
acknowledged that “this case does not involve patents on new applications of knowledge about the
BRCA1 and BRCA2 genes” (slip op 17-18). Moreover, it made no reference at all
to the rationale for the rule against patenting laws of nature offered in cases
such as Prometheus, which is that
patents based on laws of nature would monopolize or “preempt” that knowledge.
The preemption argument is also fallacious; a patentee should be able to
monopolize it inventive contribution, in order to ensure that the reward is
commensurate with the contribution. By omitting any mention of the preemption
rationale, and by affirming the patentability of applications of this
knowledge, it may be that the USSC in Myriad
Genetics has taken away with one hand, but given with the other. By
claiming all applications of the knowledge of a gene sequence, it may well be
possible to get the same practical protection that would be offered by a claim
to the isolated gene.

Note that the holding regarding cDNA was
strictly obiter. The claims at issue in the USSC were claims 1, 2, 5, 6, and 7
of U. S. Patent 5,747,282, claim 1 of U. S. Patent5,693,473, and claims 1, 6, and 7 of U. S.
Patent 5,837,492, all of which claimed an isolated
DNA molecule, and all of which are consequently invalid. In addition to these
claims, at issue were claim 20 to ‘282, claim 1 of U.S. Patent 5,709,999, claim 1 of U.S. Patent5,710,001, claim 1 of U.S. Patent 5,753,441, and claims 1 and 2 of U.S. Patent6,033,857, all of which were methods for
screening by comparing the suspect gene with the specified gene sequence. All
of these claims were held to be invalid by the Federal Circuit. Claims that
were not challenged include transformed cells, primers and kits.

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